Recalls and alerts more than 4 years old are automatically archived. While this information can still be accessed in the database, it has not been altered or updated since it was archived. Web pages that are archived on the Web are not subject to the Government of Canada Web Standards. As per the Communications Policy of the Government of Canada, you can request alternate formats by contacting us.

BBL MGIT Mycobacteria Growth Indicator Tube (2013-09-09)

Starting date:
September 9, 2013
Posting date:
October 17, 2013
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-36231

Recalled products

BBL MGIT Mycobacteria Growth Indicator Tube 

Reason

Products have been recalled for the following labelling issues.

Product contained incorrect barcodes where the labels began with ""43 02"" rather than the required ""43 01"". These batches were placed on quality notification and dispositioned for rework to over-label the barcode area with the correct symbology. The over-label was manually applied to each tube. 

One customer complaint was received where the over-label had partially peeled off of the tube, the incorrect barcode underneath was scanned into the MGIT instrument, and the epicenter connected to the customer's laboratory system incurred an error. The customer also noted that they found additional tubes in their shipment that had multiple labels or no over-label.

The label prefix, specifically the 3rd and 4th digits that indicate the media type, gives the instrument information for what algorithm to apply for growth detection. Growth detection testing will be performed by the MGIT instrument every 60 minutes as usual on tubes containing incorrect barcode prefixes, but will not flag as positive when growth is visible because media type "43 02" is not defined. A barcode overlabel peeling off, exposing an incorrect barcode, causes MGIT false negative results by not flagging positive tubes. Susceptibility tests are not affected since susceptibility testing is conducted in a carrier where instrument instruction is provided by the carrier.

Affected products

BBL MGIT Mycobacteria Growth Indicator Tube 

Lot or serial number
  • 3053240
  • 3061013
Model or catalog number
  • 245122
Companies
Manufacturer
Becton Dickinson Diagnostic Instrument Systems
7 Loveton Circle
Sparks
21152
Maryland
UNITED STATES